Novartis explains stance over India patent law challenge

Novartis has spoken out following criticism about its challenge to India's patent laws, insisting that access to life-saving drugs is not under peril by the move.

International aid agency Medecins Sans Frontieres has once again urged the Swiss major to drop its challenge to an Indian patent law, notably Section 3(d), which states that a modification of a known chemical composition is non-patentable. The legal action stems from an attempt to obtain an Indian patent on Gleevec/Glivec, Novartis' drug for chronic myeloid leukaemia and other cancers, which was denied by India's Patent Office in 2006. If the company wins the case, MSF says it could have a severe impact on access to affordable medicines for people across the developing world.

The Basel-headquartered firm has sent a statement to PharmaTimes World News saying that "we believe that working through the judicial system is the legitimate and appropriate approach to gaining clarity on the unique aspects of India’s patent law". Novartis adds that it has "confidence the Supreme Court will make the right decision based on the law of India"; a hearing is scheduled to take place next month.

Novartis goes on to say that "we disagree with assertions by a number of groups that access to medicines is threatened by our case. The basis of this argument is false and very misleading".

The company notes that currently available generic drugs launched in India before 2005 – including HIV/AIDS medicines and generic versions of Glivec – "will continue to be available under a grandfather clause [whereby an old rule continues to apply] in the Indian patent law regardless of the legal outcome of our case". Novartis also points out that "all pharmaceutical products, including HIV/AIDS medications, have been patentable in India under the existing patent law since 2005, and some have been patented".

Novartis insists that it "fully supports flexibilities in the international trade agreements that provide for countries like India to make exceptions to patent rights". They allow a government to issue a compulsory license to other companies to produce pharmaceuticals "in case of a national health crisis [and] we are not challenging these provisions".

The company highlights its many global projects such as the Glivec International Patient Assistance Programme, which has helped more than 31,000 patients in 2011 and currently provides the drug free of charge to around 15,000 patients in India - more than 95% of receiving the medicine.

The statement concludes with Novartis noting that "in pursuing this case, we are seeking clarity. We need to know if we can rely on patents in India and whether as a research-based organisation we can continue to invest in the development of better medicines for India".